GMP Specialist- Pharma Engineering in West Caldwell, NJ at Volt

Date Posted: 9/2/2021

Job Snapshot

Job Description

Engineering GMP Specialist – 1st Shift

DIRECT HIRE

Salary up to $95K

Primary Job Functions:

  • Provides general engineering GMP support to the company by seeking out engineering GMP tasks and other tasks to benefit the company.
  • Production Support: Maintains continuity of production by suggesting GMP compliant temporary solutions where necessary to keep production running.  Handles minor engineering projects as assigned.
  • Supports new business opportunities by serving as project GMP engineering resource and by defining the GMP requirements for new processes, equipment trains and their utility and facility requirements.
  • Continuous Improvement:  Analyzes current state of Engineering GMP compliance processes and suggests and implements improvement projects.
  • Maintenance and Calibration support: Supports maintenance by providing necessary GMP documents. 
  • Writes Preventive Maintenance and calibration SOP’s.
  • Qualification support: Prepares and executes documents related to equipment and facility qualification such as URS, FAT, SAT, IQ, and OQ protocols.  Reviews similar document prepared by internal or external sources.
  • Deviation Investigation support: Leads investigations to determine root causes and CAPAs.  Manages CAPA’s through completion.
  • Audit support: Prepares for audits by collecting and analyzing relevant documents for compliance issues.  Maintains document lists or other means to identify documents needed for audits.  Develops responses to audit questions.  Represents the department face-to-face with auditors.
  • Team and Leadership skills: Serves as GMP representative for department.
  • Subject Matter Competency: Maintains competency by keeping informed about GMP compliance systems used on location

QUALIFICATIONS/REQUIREMENTS: 

  • Minimum Bachelors in engineering or related
  • At least 4 years’ experience in pharmaceutical, manufacturing or related field
  • Excellent mathematics, reading, writing and verbal skills
  • Intermediate or advanced in word, power point and excel
  • Excellent team player and strong complaint resolution skills
  • Ability to wear safety glasses, hearing protection, full face/half mask respirator, latex gloves, Tyvek suit and other safety equipment as needed
  • Basic use of tools and equipment
  • PREFERRED: Engineer or scientist with experience in pharmaceutical manufacturing, process engineer, mechanical engineer, chemistry, biotechnology, electrical engineering, automation engineer or similar studies

Volt is an Equal Opportunity Employer